A Study of JNJ-68284528 Out‐of‐Specification (OOS) for Commercial Release in Participants with Multiple Myeloma

Last Updated   December 21, 2022 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    25 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out‐of‐specification (OOS).

CONDITIONS

  • Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

  • • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
  • • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re‑manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
  • • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
  • • Meets the criteria to receive lymphodepleting chemotherapy
  • • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

  • • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
  • • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
  • • Hepatitis B infection
  • • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
  • • Seropositive for human immunodeficiency virus (HIV)
  • • Uncontrolled autoimmune disease

DETAILS

LOCATIONS

Locations in:
United States, Japan
Country (2) City or Province (25) Status
United States Atlanta, GA Emory University
Recruiting
United States Boston, MA Beth Israel Deaconess Medical Center
Not yet recruiting
United States Boston, MA Dana-Farber Cancer Institute
Recruiting
United States Boston, MA Massachusetts General Hospital
Recruiting
United States Charlotte, NC Levine Cancer Institute
Recruiting
United States Chicago, IL Northwestern University
Recruiting
United States Denver, CO Colorado Blood Cancer Institute
Recruiting
United States Detroit, MI Barbara Ann Karmanos Cancer Institute
Recruiting
United States Duarte, CA City of Hope
Recruiting
United States Hackensack, NJ Hackensack University Medical Center
Recruiting
United States Houston, TX MD Anderson Cancer Center
Recruiting
United States Jacksonville, FL Mayo Clinic
Withdrawn
United States Miami, FL University of Miami Sylvester Comprehensive Cancer Center
Not yet recruiting
United States Milwaukee, WI Medical College Of Wisconsin
Recruiting
United States New York, NY Memorial Sloan Kettering Cancer Center
Recruiting
United States New York, NY Mount Sinai Medical Center
Recruiting
United States Pittsburgh, PA University of Pittsburgh Medical Center
Recruiting
United States Rochester, MN Mayo Clinic - Rochester
Not yet recruiting
United States Saint Louis, MO Washington University School of Medicine
Recruiting
United States San Francisco, CA University of California, San Francisco
Recruiting
United States Seattle, WA University of Washington-Fred Hutchinson Cancer Research Center
Not yet recruiting
United States Stanford, CA Stanford University Medical Center
Recruiting
United States Tampa, FL H. Lee Moffitt Cancer Center and Research Institute
Not yet recruiting
United States Westwood, KS Kansas University Medical Center
Recruiting
Japan Nishinomiya-shi, 28 Hyogo Medical University Hospital
Not yet recruiting
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50

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10

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5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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